Project Orbis
The Food & Drug Administration is working in collaboration with countries around the world to help provide additional treatment options for patients battling cancer. In 2019, Project Orbis was established by the Food & Drug Administrations Oncology Center of Excellence (OCE), to expedite drug approvals in countries with prolonged regulatory submissions.
According to the OCE:
Collaboration among international regulators may allow patients with cancer to receive earlier access to products in other countries where there may be significant delays in regulatory submissions, regardless of whether the product has received FDA approval. Pivotal clinical trials in oncology are commonly conducted internationally and these global trials are increasingly important for investigating the safety and effectiveness of cancer drugs for approval in the United States.
Who are the OCE?
Established in 2017, the OCE is a group of regulatory scientists and reviewers with experience in drugs, biologics, devices, and diagnostics. Their vision is to “create a unified and collaborative scientific environment to advance the development and regulation of oncology products for patients with cancer.”.
Since their establishment, the OCE has clinically reviewed medications for approval such as abemaciclib, durvalumab, niraparib, brigatinib and many more. A complete list of these medications can be viewed here.
OCE has setup several programs including Project Obris to work towards their next initiative “Project 2025”.
According to OCEs Director, Dr. Richard Pazdur:
As we enter OCE’s third year, we are embarking on Project 2025, an initiative to envision the next five years in cancer drug development and leverage our resources and talents to improve collaboration with stakeholders and move the field forward as quickly as possible.
The OCE works with FDA Product Centers to determine which drugs should be enrolled for expedited approvals. Once a drug is determined to be eligible for expedited approval, the OCE forms a Medical Oncology Review and Evaluation (MORE) team. This team then does a complete clinical review of the product and submits it to the product center for the final application approval determination.
Project Obris Reviews
Currently, there is only one drug therapy that has been reviewed under Project Obris. OCE worked closely with the Australian Therapeutic Goods Administration and Health Canada to complete a clinical review for the use of Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) for patients with advanced endometrial cancer. This review led to the accelerated approval for this combination therapy in all 3 collaborating countries (United States, Australia & Canada).
New indication added as of September 2019 for Lenvima (lenvatinib):
In combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
For more information about the FDAs Oncology Center of Excellence (OCE) and their programs, visit their website or follow them on social media.
Thank you for reading,
Peter Austin
Class of 2020 PharmD. Candidate from Fairleigh Dickinson University School of Pharmacy & Health Sciences.
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